A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy



Status:Completed
Conditions:Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2012
End Date:September 2014

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A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Evaluate The Efficacy And Safety Of Once-daily Administration Of A Chemokine Ccr2/5 Receptor Antagonist (Pf-04634817) In Adults With Type 2 Diabetes And Overt Nephropathy

The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects
with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a
surrogate for improved glomerular filtration.


Inclusion Criteria:

- Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based
on an eGFR of 20-75 mL/min/1.73m2.

- Evidence of persistent, overt albuminuria; defined as a UACR >=300 mg/g (>=33.9
mg/mmol) or UPCR >=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.

- Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB,
which may also include an aldosterone antagonist in double RAAS but not triple RAAS
inhibitor therapy) for at least 3 months before screening and to be maintained for
the duration of the study.

Exclusion Criteria:

- Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.

- Subjects who are diagnosed with autosomal dominant polycystic kidney disease
(ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.
We found this trial at
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Pembroke Pines, Florida 33028
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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Albuquerque, New Mexico 87109
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Asheville, North Carolina 28801
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Burke, Virginia 22015
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Champaign, Illinois 61820
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Chula Vista, California 91910
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Clearwater, Florida 33756
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Covina, California 91723
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Doral, Florida 33126
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Flint, Michigan 48504
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Greenville, North Carolina 27834
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Greenville, Texas 75402
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Hialeah, Florida 33012
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Houston, Texas 77074
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Houston, Texas 77099
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Huntington Beach, California 92648
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Kansas City, Missouri 64128
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Little Rock, Arkansas 72205
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Los Angeles, California 90048
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Manassas, Virginia 20110
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Memphis, Tennessee 38119
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Metairie, Louisiana 70006
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Milwaukee, Wisconsin 53295
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Morehead City, North Carolina 28557
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Paducah, Kentucky 42003
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Providence, Rhode Island 02904
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Richmond, Texas 77469
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Statesville, North Carolina 28625
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